Corporate Headquarters
Genzyme Corporation
500 Kendall Street
Cambridge, MA 02142
USA
Manufacturer / Distributor
Genzyme Diagnostics
6659 Top Gun Street
San Diego, CA 92121
USA
Phone: 617-252-7500
Phone: 858-452-3198
Distributor
Genzyme Diagnostics
50 Gibson Drive
Kings Hill, West Malling
Kent ME19 4AF
UK
Distributor
Genzyme Diagnostics
One Kendall Square
Cambridge, MA 02139
USA
Phone: 800-332-1042
Phone: +44 (0) 1732 220022
MATERIAL SAFETY DATA SHEETS
Catalog Number:
190, 190E
Item Number:
2077
Kit Name:
OSOM® Influenza A&B Test
Component Name:
OSOM® Influenza A&B Test Extraction Buffer
The Influenza A Positive Control Swab is an “article” and does not require an MSDS.
The Influenza B Positive Control Swab is an “article” and does not require an MSDS.
Effective Date: August 24, 2007
MATERIAL SAFETY DATA SHEET
OSOM® Influenza A&B Test Extraction Buffer
1. PRODUCT AND COMPANY IDENTIFICATION
.
Product Name: OSOM® Influenza A&B Test Extraction Buffer
Synonym(s): Extraction Buffer
Product Use: Component of OSOM® Influenza A&B Test kit (catalog # 190, 190E). For use in the
qualitative detection of influenza A and B viral antigens. For In Vitro Diagnostic Use Only.
Description: Aqueous solution containing salts, detergent, albumin protein and bacteriocide.
Corporate Headquarters
Genzyme Corporation
500 Kendall Street
Cambridge, MA 02142
USA
Phone: +1 617-252-7500
Manufacturer/Distributor
Genzyme Diagnostics
6659 Top Gun Street
San Diego, CA 92121
USA
Phone: +1 858-452-3198
Distributor
Genzyme Diagnostics
50 Gibson Drive
Kings Hill, West Malling
Kent, ME19 4AF
UK
Phone: +44 (0) 1732 220022
Distributor
Genzyme Diagnostics
One Kendall Square
Cambridge, MA 02139
USA
Phone: 1-800-332-1042
Emergency Telephone Numbers
Genzyme (U.S.): +1 617-562-4555
CHEMTREC (U.S.): 1-800-424-9300
CHEMTREC (Outside U.S.): +1 703-527-3887
2. HAZARDS IDENTIFICATION
.
Precautionary Statements:
The chemical, physical and toxicological properties of this preparation have not been thoroughly characterized. May
be irritating to eyes and skin. Avoid contact with eyes and skin. Do not ingest or inhale. The bovine serum albumin
(BSA) in this product is of US origin. The BSA was obtained from a supplier who holds a Certificate of Origin,
Certificate of Analysis, and/or an EDQM Certificate of Suitability documenting the evaluation of reduction of TSE
(Transmissible Spongiform Encephalopathy) risk. Preparation appearance: clear, colorless liquid.
Routes of Exposure:
Occupational exposure routes may include eye and skin contact.
Potential Health Effects:
Inhalation
Aerosol inhalation may cause coughing and sore throat.
Eye
Eye exposure may cause irritation, redness and watering.
Skin
Skin contact may cause irritation, dryness and redness.
Ingestion
No data available.
Chronic Effects
No data available.
Target Organs
Unknown.
Regulatory Status:
This preparation is not classified as hazardous under U.S. OSHA 29 CFR 1910.1200; E.C. Directive 1999/45/EC;
Canadian R.S. 1985, c. H-3; U.K. CHIPS 2002 No. 1689; or U.N. GHS ST/SG/AC 10/30.
None of the components present in this preparation at concentrations equal to or greater than 0.1% are listed by
IARC, NTP, OSHA or ACGIH as a carcinogen.
Effective Date: August 24, 2007
Date Printed: August 24, 2007
2077-2
Page 1 of 6
MATERIAL SAFETY DATA SHEET
OSOM® Influenza A&B Test Extraction Buffer
Potential Environmental Effects:
Unknown.
.
3. COMPOSITION / INFORMATION ON INGREDIENTS
.
CAS #
Ingredient Name
Water
7732-18-5
% (wt/wt)
231-791-2
95 - 96
223-264-0
2-3
Trade Secret
<1
231-598-3
<1
231-448-7
<1
232-936-2
<1
203-473-3
<1
247-852-1
< 0.1
231-449-2
< 0.1
247-500-7
< 0.01
Not Assigned
< 0.01
220-239-6
< 0.01
EC Hazard Class: None
EC R-Phrases: None
L-Aspartic acid, monosodium salt
3792-50-5
EC Hazard Class: None
EC R-Phrases: None
Trade Secret Detergent
Trade Secret
EC Hazard Class: Xn
EC R-Phrases: R36/38
7647-14-5
Sodium chloride
EC Hazard Class: Xi
EC R-Phrases: R36/38
Sodium phosphate dibasic, anhydrous
7558-79-4
EC Hazard Class: Xi
EC R-Phrases: R36/38
Bovine serum albumin
9048-46-8
EC Hazard Class: None
EC R-Phrases: None
107-21-1
Ethylene glycol
EC Hazard Class: Xn
EC R-Phrases: R22
Sodium azide
26628-22-8
EC Hazard Class: T+, N
EC R-Phrases: R28, R32, R50, R53
Sodium phosphate monobasic dihydrate
13472-35-0
EC Hazard Class: None
EC R-Phrases: None
Methylchloroisothiazolinone
26172-55-4
EC R-Phrases: R23/24/25, R34, R43, R50/53
Modified alkyl carboxylate
EC Hazard Class: C, T, N
Not Assigned
EC Hazard Class: None
EC R-Phrases: None
Methylisothiazolinone
2682-20-4
EC R-Phrases: R23/24/25, R34, R43, R50/53
.
EC #
EC Hazard Class: C, T, N
4. FIRST AID MEASURES
Inhalation:
If inhaled, move from exposure area to fresh air. Seek medical attention if breathing becomes difficult or if cough or
other symptoms develop.
Eye Contact:
Immediately flush eyes with plenty of tepid water for 15 minutes while separating eyelids with fingers. Remove contact
lenses if worn. Obtain medical attention if needed or if symptoms, such as redness or irritation persist.
Skin Contact:
In case of contact, flush skin with copious amounts of cool water and remove contaminated clothing. Obtain medical
attention if needed or if irritation or other symptoms develop.
Ingestion:
In case of ingestion, contact a poison control center or physician for instructions.
Effective Date: August 24, 2007
Date Printed: August 24, 2007
2077-2
Page 2 of 6
MATERIAL SAFETY DATA SHEET
OSOM® Influenza A&B Test Extraction Buffer
5. FIRE FIGHTING MEASURES
.
Flammable Properties:
Dilute aqueous solution not considered a fire hazard.
Suitable Extinguishing Media:
Use extinguishing media suitable for surrounding fire, such as carbon dioxide, chemical foam, dry chemical or water
spray.
Unsuitable Extinguishing Media:
Unknown.
Specific Hazards Arising from the Chemical:
None expected.
Standard Protective Equipment and Precautions for Firefighters:
Firefighters should wear NIOSH-approved or equivalent Self-Contained Breathing Apparatus and full protective gear.
6. ACCIDENTAL RELEASE MEASURES
.
Personal Precautions:
Wear Personal Protective Equipment (PPE) as indicated in Section 8. Avoid physical contact with material. Wash
hands thoroughly after handling.
Environmental Precautions:
This preparation contains a small amount of sodium azide which can react with copper, lead, brass or solder in
plumbing systems and form potentially explosive metal azides. Follow proper disposal procedures.
Methods and Materials for Containment and Clean-Up:
Absorb spill with inert material/sorbent. Decontaminate the spill site following standard procedures. Dispose of
materials in accordance with all applicable federal, state, local and provincial environmental regulations, per Section
13.
7. HANDLING AND STORAGE
.
Handling:
Follow good laboratory hygiene practices. See Section 8, Engineering Controls. Minimize contact and contamination
of personal clothing and skin. Wash hands thoroughly after handling.
Storage:
Store at room temperature, 15 to 30°C (59 to 86°F). Do not store with incompatible substances; see Section 10.
.
8. EXPOSURE CONTROLS / PERSONAL PROTECTION
Exposure Guidelines:
There are no ACGIH, NIOSH, OSHA or country-specific occupational exposure limits currently established for
components present in this preparation at concentrations equal to or greater than 1% (0.1% if carcinogen).
Engineering Controls:
This preparation is aqueous and non-volatile and is not expected to require special ventilation measures. Facilities
storing or utilizing this preparation should be equipped with an eyewash fountain.
Personal Protective Equipment (PPE):
Respiratory
A respirator is not required under normal conditions of use.
Eye/Face
Wear appropriate protective safety eye glasses or goggles.
Effective Date: August 24, 2007
Date Printed: August 24, 2007
2077-2
Page 3 of 6
MATERIAL SAFETY DATA SHEET
OSOM® Influenza A&B Test Extraction Buffer
Personal Protective Equipment (PPE):
Skin
Wear lab coat or other protective garments. Remove contaminated clothing promptly.
Gloves
Wear chemical resistant protective gloves.
General
Follow company-specific safety procedures.
9. PHYSICAL AND CHEMICAL PROPERTIES
.
Appearance:
Clear, colorless liquid
pH:
7.6 (approx.)
Odor:
Not available
Solubility:
Water-soluble
Boiling Point:
Not available
Vapor Pressure:
Not available
Melting Point:
Not applicable
Not available
Partition Coefficient
(n-octanol/water):
Not available
Freezing Point:
Vapor Density:
Not available
Flammability/Explosivity Limits in Air, Lower:
Flammability/Explosivity Limits in Air, Upper:
Auto-Ignition Temperature: Not applicable
Not available
Flash Point:
.
Not available
Not available
10. STABILITY AND REACTIVITY
Chemical Stability:
Stable under ordinary conditions of use and storage; (see handling and storage information in Section 7).
Conditions to Avoid:
There are no physical conditions known to result in a hazardous situation.
Incompatible Materials:
Avoid strong oxidizers, strong acids and bases, heavy metals and their salts.
Hazardous Decomposition Products:
None expected under normal conditions of use.
Possibility of Hazardous Reactions:
Hazardous polymerization will not occur.
.
11. TOXICOLOGICAL INFORMATION
Acute Effects:
No data available.
Local Effects:
No data available.
Chronic Effects:
No data available.
Carcinogenicity:
None of the components present in this preparation at concentrations equal to or greater than 0.1% are listed by
IARC, NTP, OSHA or ACGIH as a carcinogen.
Effective Date: August 24, 2007
Date Printed: August 24, 2007
2077-2
Page 4 of 6
MATERIAL SAFETY DATA SHEET
OSOM® Influenza A&B Test Extraction Buffer
Mutagenicity:
No data available.
Teratogenicity:
No data available.
Reproductive Effects:
No data available.
Sensitization:
No data available.
12. ECOLOGICAL INFORMATION
.
Ecotoxicity:
No data available.
Persistance and Degradability:
No data available.
Bioaccumulative Potential:
No data available.
Mobility in Environmental Media:
No data available.
.
13. DISPOSAL CONSIDERATIONS
Methods of Disposal:
This preparation contains a small amount of sodium azide which can react with copper, lead, brass or solder in
plumbing systems and form potentially explosive metal azides. If preparation enters drain, flush with a large volume of
water to prevent azide build-up. Dispose of unused product, spilled material and waste in accordance with all applicable
federal, state, local and provincial environmental and hazardous waste regulations.
.
14. TRANSPORT INFORMATION
Basic Shipping Description:
Not classified as dangerous goods. Not regulated per IATA and DOT regulations.
.
15. REGULATORY INFORMATION
US Federal Regulations:
This preparation is a component of an FDA-regulated in vitro diagnostic device.
Inventory - United States - Section 8(b) Inventory (TSCA)
L-Aspartic acid, monosodium salt
3792-50-5
Effective Date: August 24, 2007
Date Printed: August 24, 2007
Present
2077-2
Page 5 of 6
MATERIAL SAFETY DATA SHEET
OSOM® Influenza A&B Test Extraction Buffer
International Regulations:
If approved for European Communities use, this product is regulated under the In Vitro Diagnostic Medical Devices Directive
(98/79/EC).
Inventory - Canada - Non-Domestic Substances List (NDSL)
L-Aspartic acid, monosodium salt
3792-50-5
Present
Inventory - European Union - European Inventory of Existing Commercial Chemical Substances (EINECS)
L-Aspartic acid, monosodium salt
3792-50-5
223-264-0
Inventory - Japan Existing and New Chemical Substances (ENCS)
L-Aspartic acid, monosodium salt
3792-50-5
2-1308
Canadian Hazardous Products:
Non-controlled
WHMIS Status
European Communities Dangerous Substances/Preparations:
EC Hazard Class None
Risk Phrases None
Safety Phrases None
.
16. OTHER INFORMATION
Further Information:
This MSDS has been prepared in accordance with the ANSI Z400.1 format. Every effort has been made to adhere to the hazard criteria
and content requirements of the US OSHA Hazard Communication Standard, European Communities Safety Data Sheets Directive,
Canadian Controlled Products Regulations, UK Chemical Hazard Information and Packaging Regulations, and UN Globally Harmonized
System of Classification and Labelling of Chemicals.
MSDS Origination Date: July 24, 2006
Version #: 3
Revision Date: August 24, 2007
Disclaimer:
The information above is provided in good faith. It is believed to be accurate and represents the best information currently available to
us. HOWEVER, WE MAKE NO WARRANTY OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE OR OF ANY
OTHER TYPE, EXPRESSED OR IMPLIED, WITH RESPECT TO PRODUCTS DESCRIBED OR DATA OR INFORMATION
PROVIDED, AND WE ASSUME NO LIABILITY RESULTING FROM THE USE OF SUCH PRODUCTS, DATA OR INFORMATION.
Users should make their own investigations to determine the suitability of the information for their particular purposes, and the user
assumes all risk arising from their use of the material. The user is required to comply with all laws and regulations relating to the
purchase, use, storage and disposal of the material, and must be familiar with and follow generally accepted safe handling procedures.
In no event shall Genzyme be liable for any claims, losses, or damages of any individual or for lost profits or any special, indirect,
incidental, consequential or exemplary damages, howsoever arising, even if Genzyme has been advised of the possibility of such
damages.
Effective Date: August 24, 2007
Date Printed: August 24, 2007
2077-2
Page 6 of 6